BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VITAL SUTURES, SUTUREX, CIRUGIA PERUANA

    K Number: K100780 · Decision Dec 14, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    63
    Applicant Total
    2
    Review Days
    270

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    Basic Information

    Device Name
    VITAL SUTURES, SUTUREX, CIRUGIA PERUANA
    K Number
    K100780
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4840
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Unilene Sac
    Date Received
    March 19, 2010
    Decision Date
    December 14, 2010
    Product Code
    NEW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NEW Suture, Surgical, Absorbable, Polydioxanone

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    Other Clearances by Unilene Sac

    K Number Device Name
    K123034 VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED